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Schutzimpfung gegen Rotavirusgastroenteritis

Assoziation mit dem Kawasaki-Syndrom?

Vaccination against gastroenteritis caused by rotavirus

Association with Kawasaki disease?

  • Arzneimitteltherapie
  • Published:
Monatsschrift Kinderheilkunde Aims and scope Submit manuscript

Zusammenfassung

Hintergrund

Die Ätiologie des Kawasaki-Syndroms (KS) ist ungeklärt, zuletzt wurde die Impfung zur Prävention einer Rotavirengastroenteritis mit ihm in Zusammenhang gebracht.

Material, Methoden und Ergebnisse

Es wurden eine Datenabfrage zum Kawasaki-Syndrom nach Impfung mit RotaTeq® bzw. Rotarix® durchgeführt und alle seit Inkrafttreten (2001) des Infektionsschutzgesetz (IfSG) in Deutschland gemeldeten Verdachtsfälle bis zum 30.06.2010 – insgesamt 4 Fälle nach Impfung mit RotaTeq®, kein Fall nach Impfung mit Rotarix® – rekapituliert. Zwar wurde KS nach RotaTeq®-Impfung in Deutschland im Vergleich zu anderen Kinderimpfstoffen häufiger gemeldet, allerdings lässt sich kein Muster hinsichtlich Alter, Geschlecht und Intervall bis zum Auftreten erkennen.

Schlussfolgerungen

Aus spontan gemeldeten Verdachtsfällen einer Nebenwirkung/Impfkomplikation kann nicht automatisch auf einen ursächlichen Zusammenhang geschlossen werden. Zurzeit sprechen die Analyse der Spontanmeldungen zu Verdachtsfällen von KS aus Europa und den USA sowie die Daten einer prospektiven Beobachtungsstudie nach der Zulassung nicht für ein erhöhtes Risiko nach Impfung gegen Rotavirengastroenteritis. Trotzdem sollten alle KS-Verdachtsfälle nach einer Impfung zeitnah gemeldet werden.

Abstract

Background

The etiology of Kawasaki disease (KD) is unknown. Recently, the vaccination for prevention of gastroenteritis caused by rotavirus has been associated with it.

Material, methods and results

A “structured query language” (SQL) search for the term “Kawasaki disease” and vaccination with RotaTeq® or Rotarix® was performed and all German KD cases reported since enactment (2001) of the IfSG (German law for protection against infections) through 30 June 2010 – a total of four KD cases after vaccination with RotaTeq® and no case after vaccination with Rotarix®, respectively – were reviewed. The four KD cases after vaccination with RotaTeq® revealed no clustering regarding age, gender and time to onset of the adverse drug reaction (ADR).

Conclusions

Currently, the analysis of spontaneously reported cases of suspected KD from Europe and the USA as well as data emerging from a prospective post-licensure observational study do not support an increased KD risk after vaccination against gastroenteritis caused by rotavirus. Nevertheless, it is essential to thoroughly monitor the detected association. Physicians are encouraged to reasonably soon report all KD cases occurring after a vaccination to the German regulatory authority.

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Authors and Affiliations

  1. Referat Pharmakovigilanz S1, Paul-Ehrlich-Institut, Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel, Paul-Ehrlich-Straße 51–59, 63225, Langen, Deutschland

    D. Oberle MSc., C. Pönisch, K. Weißer, B. Keller-Stanislawski & D. Mentzer

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  1. D. Oberle MSc.
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  2. C. Pönisch
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  3. K. Weißer
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  4. B. Keller-Stanislawski
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Correspondence to D. Oberle MSc..

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Oberle, D., Pönisch, C., Weißer, K. et al. Schutzimpfung gegen Rotavirusgastroenteritis. Monatsschr Kinderheilkd 158, 1253–1260 (2010). https://doi.org/10.1007/s00112-010-2309-y

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